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Non-opioid Analgesic

Opioid-Free Pain Management for Postoperative Pain

Phase 4
Recruiting
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to take oral medication and be willing to adhere to the study intervention
All female patients over 18 years of age from the Northwell Health urogynecology offices in Bay Shore, Syosset, and Huntington, NY who are undergoing transvaginal minor urogynecologic surgery (midurethral sling, periurethral bulking injections, anterior repair, posterior repair, and perineorrhaphy) at South Shore Surgery Center
Must not have
Patients with a history of asthma, urticaria, or other allergic type reactions after taking aspirin or other NSAIDS or DRESS, history of gastric bypass surgery, heart failure, active GI ulcer, active GI bleeding, inflammatory bowel disease, cerebrovascular bleeding, liver impairment/hepatic disease, hyperkalemia
Both non-English and non-Spanish speaking patients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

"This trial aims to see if taking a combination of acetaminophen, celecoxib, and gabapentin before surgery can help patients undergoing minor urogynecologic procedures to urinate quicker after

Who is the study for?
This trial is for patients scheduled for same-day minor urogynecologic surgeries who can take medications like acetaminophen, celecoxib, and gabapentin. Specific eligibility criteria are not provided.
What is being tested?
The study tests if taking a combination of acetaminophen, celecoxib, and gabapentin before surgery helps patients recover bladder function faster than just acetaminophen alone. It's a randomized control trial with two groups.
What are the potential side effects?
Possible side effects may include digestive issues from celecoxib or gabapentin, allergic reactions, dizziness or fatigue. Acetaminophen could cause liver damage if taken in high doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take pills and will follow the study's treatment plan.
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I am a woman over 18, seeing a urogynecologist in Bay Shore, Syosset, or Huntington, NY for surgery like sling placement or pelvic repair.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of severe allergies to NSAIDs, specific medical conditions like heart failure, or liver disease.
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I do not speak English or Spanish.
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I am allergic to acetaminophen, celecoxib, gabapentin, or their ingredients.
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I am under 18 years old.
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I do not have Myasthenia Gravis, severe kidney issues, seizures, substance use disorder, allergies to gabapentin, DRESS syndrome, driving impairment, increased seizures, suicidal behavior or respiratory depression.
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I cannot take NSAIDs due to my kidney problems.
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I have a serious heart condition.
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I have recently experienced increased swelling or fluid buildup.
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I am currently taking gabapentin.
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I have had surgery for pelvic organ prolapse.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care (SOC) (acetaminophen) and investigational product (celecoxib + gabapentin)Experimental Treatment3 Interventions
one time dose of 1000mg acetaminophen orally combined with 400mg celecoxib orally, and 300mg gabapentin orally
Group II: Standard of Care (SOC) (acetaminophen)Active Control1 Intervention
one time dose of 1000mg acetaminophen orally
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetaminophen
2017
Completed Phase 4
~2030
Celecoxib
2019
Completed Phase 4
~1740
Gabapentin
2013
Completed Phase 4
~1550

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
474 Previous Clinical Trials
469,090 Total Patients Enrolled
4 Trials studying Postoperative Pain
372 Patients Enrolled for Postoperative Pain
~44 spots leftby Mar 2026
Unbiased ResultsWe believe in providing patients with all the options.
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